341 Method Development Jobs - Page 6

As a part of this role, you will be responsible for method development, method validation, and routine analysis in Orals and Non-orals Formulations. Your area of experience will include conducting the Microbial Enumeration Test, Test for specified Micro-organisms, Bio-burden Test, Antimicrobial Effectiveness Test, Sterility Test, Bacterial Endotoxin Test, Microbiological Assay, Microbial Culture propagation, maintenance, and enumeration, Growth Promotion Test, as well as Environment monitoring. In addition to the above, you will also be involved in the preparation of SOP's/STP's/Documentation, calibration of laboratory equipment/Instrument, ensuring work is conducted as per cGMP/GLP Compliance, and having exposure to LIMS. Your role is crucial in ensuring the accuracy and reliability of testing procedures and results, and your expertise in various microbiological tests will contribute significantly to the overall quality and compliance standards of the organization.,

As a highly motivated scientist joining our dynamic research team, you will be required to have an educational qualification of M.Pharm / M.Sc. (Chemistry) and possess extensive basic knowledge of modern analytical techniques. Your role will involve analyzing raw materials, in-process, and finished products while generating analytical data with accuracy and adequacy. You will be responsible for the preparation of reference, working, and impurity standards, ensuring the timely completion of assigned training modules, and maintaining the availability of consumables for experimental activities. Your expertise in handling analytical techniques such as Spectroscopy (UV-Vis, FT-IR), Chromatography (HPLC), and other instruments like Potentiometric titrator and KF will be vital for this role. Additionally, you should have knowledge of method development, stability analysis, cGMP, GLP, and GDP procedures. Understanding development activities and processes in the pharmaceutical industry is essential, along with maintaining accurate records of research activities and results. You will play a key role in maintaining a safety and quality culture, participating in lab activities to ensure compliance, and following appropriate safety practices in the workplace. It is important to actively contribute to achieving team goals, communicate information clearly and impartially, and enforce safety requirements related to your job function. This position is based on-premise, and Pfizer is an equal opportunity employer that complies with all applicable equal employment opportunity legislation. If you are a motivated scientist with a background in pharmaceutical research and the required educational qualifications and experience, we encourage you to apply to be part of our Research and Development team.,

The Associate QA Executive at House of Spices is responsible for performing quality assurance duties at a professional level and collaborating closely with the QA, Purchase, Supply Chain, and other staff members to support designated geographic regions. Key Responsibilities: Perform and accurately document quality checks on products and regulatory checks in accordance with company programs and USFDA regulations. Compile and maintain inspection reports and records. Conduct product sampling and inspection using standard methods and procedures, including sensory evaluation as needed. Record, manage, and handle samples in the lab as required. Support the FSQA Manager/Executive in monitoring processes, analyzing data, and driving continuous improvement to minimize food safety risks. Assist in the development, implementation, auditing, and maintenance of the Food Safety and Quality System to ensure compliance with regulatory standards. Preferred candidates should have experience in Spices, Commodities (Flour, Rice, Dals), Frozen RTE, Frozen Vegetables, and RTE Snacks. Conduct routine and non-routine analysis of samples, operate and maintain lab instruments, and ensure proper record-keeping of test results. Perform tests such as moisture, ash content, oil content, FFA & PV, pH, Brix, Acidity, and other relevant tests following specifications or standards. Prepare and standardize reagents and chemical solutions, adhere to good laboratory practices, hygiene, and safety protocols, and calibrate lab instruments. Occasional travel may be required for this role. Required Qualifications: Bachelor's degree in food science/food technology or equivalent field. Knowledge of lab techniques for analyzing various food products. Proficiency in MS Word, Excel, and PowerPoint. Strong organoleptic senses for product and sensory evaluation. Preferred Qualifications: Understanding of lab techniques and prior training in fundamental quality assurance technology. Basic knowledge of Quality Assurance, GFSI, Regulatory standards (US FDA), FSMA, and other regulatory requirements. Good technical skills, communication skills, problem-solving abilities, and experience working in a start-up environment. Key Competencies: Teamwork. Effective communication. Consultation. Ethical practice. Problem-solving. Relationship management. Join House of Spices to contribute to the celebration of authentic ethnic food and flavors in North America while ensuring the highest standards of quality and safety in the industry.,

Business - Research & Development Department - ADL ( API ) Position - Research associate to Team Lead Qualification - M.Sc./M.Pharm Experience - 3 to 8 Years Contact - Sharad Yadav ( HR ) - sharad.yadav@cadilapharma.com

Job Summary We are seeking a highly skilled Analytical Scientist to join our Research and Development team. The successful candidate will be responsible for developing, validating, and implementing analytical methods for the quantification and identification of genotoxic impurities in pharmaceutical products. This role will involve extensive use of chromatography techniques and adherence to regulatory standards. The ideal candidate should have a strong background in analytical chemistry, method development, and data analysis, with a keen eye for detail and a commitment to ensuring the highest quality standards. Roles & Responsibilities You will be responsible to review relevant Literature and stay updated with the latest research and scientific literature relevant to the field of genotoxic impurities and chromatography methods. You will be responsible to develop and optimize chromatography-based methods for accurately quantifying genotoxic impurities in various samples. You will be responsible to address regulatory deficiency queries concerning the analytical methods and data related to genotoxic impurities. You will be responsible to ensure the quality and accuracy of reference standards and working standards used in analytical testing and method development. You will be responsible to develop analytical methods, conduct validation studies to ensure the accuracy and reliability of the methods, and transfer validated methods to the Quality Control (QC) department. You will be responsible to prepare comprehensive reports documenting method development, validation results, and any forced degradation studies performed. You will be responsible to conduct forced degradation studies to identify potential impurities and establish their chemical nature and behaviour. You will be responsible to perform real-time analysis of samples during product development stages to ensure product quality and consistency. You will be responsible for compilation of Stability Data to assess the stability profile of the products under various conditions. You will be responsible to evaluate the effectiveness of the product development strategy and identify any cross-functional issues affecting the process. You will be responsible to identify and plan for the developmental needs of the product, considering factors such as scale-up and potential process improvements. You will be responsible to source and manage the procurement of necessary chemicals, solvents, columns, and other laboratory equipment. You will be responsible to ensure proper maintenance of laboratory equipment as per Good Laboratory Practices (GLP) standards to guarantee accurate and reliable results. You will be responsible to calibrate instruments as per the calibration schedule and strictly follow Standard Operating Procedures (SOPs) to maintain consistency and accuracy. You will be responsible to maintain a clean and organized work area, and ensure that the laboratory environment is controlled at the required temperature for optimal analytical conditions. You will be responsible to keep all relevant documents well-maintained and organized for easy access and compliance with internal and external auditing requirements. Qualification Educational qualification: Masters in Science/ Organic chemistry Minimum work experience: 4 years of experience in analytical method development Skills & attributes: Technical Skills Have work experience on Process scale up of Active Pharmaceutical Ingredients. Experience in Process Optimization (Manufacturing) Experience in the development and regular analysis in Wet analysis-IR, Ultra Violet, Moisture analysis, Chromatographic techniques Strong understanding of regulatory guidelines and industry standards related to pharmaceutical product development and analysis. Proven experience in method validation and documentation in compliance with regulatory requirements. Behavioral Skills Excellent communication and interpersonal skills. Strong analytical and problem-solving abilities. Ability to work collaboratively with own team and cross-functional teams. Additional Information About the Department Integrated Product Development Organisation We integrate our deep science capabilities and cutting-edge technology to develop innovative, accessible and affordable therapies for patients worldwide. We are a science-driven, innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API, Formulations, Clinical, Intellectual Property and Regulatory Affairs. We are serving 55+ markets including USA, Canada, Europe, China, LATAM, ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API), Oral formulations, Parenteral (Injectables, Opthalmics) & Other dosages Our product development efforts drive a portfolio of more than 1,000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates, we have filed 1,071 patents and also published over 1,000 papers for peer review over the years. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/

You get to collaborate on: Work closely with discovery specialists, disease area scientists and in vivo team members. Handling of laboratory animals like rat, mice, Guniea Pig and Rabbits. Dose administration to experimental animals by different routes and small animals surgery (like cannulations, CSF fluid collection) and handling, followed by compound dose preparation, administration to experimental animals. Contributing to the ongoing drug discovery programs by conducting in vivo DMPK studies for NCEs with a good knowledge of in vivo animal models. Data generation, analysis, compilation, report preparation. Regular uploading of the data. Conduct statistically supported data (analysis using win online) and deliver results in a timely manner to enable informed decision-making Understanding systems, processes, and compliance. Prepare, review, and deliver scientific presentations for internal/external use. Participate in cross-functional team activities, add value to research projects through creative ideas. Learn from top-notch drug discovery scientists across the world and opportunity to get trained in people skills. PK-PD studies in rat and mice of NCE.

You will be responsible for overseeing routine proximate testing of food samples in the Proximate Analysis Department of our Food Testing Laboratory. Your duties will include supervising and coordinating daily operations, managing a team of lab analysts, ensuring quality control, maintaining compliance with regulatory standards, and contributing to method development and troubleshooting. Key Responsibilities: - Supervise and coordinate daily operations of the Proximate Department, including tasks related to Moisture, Ash, Protein, Fat, Fiber, etc. - Allocate tasks and manage workflow of lab analysts and technicians to ensure timely and accurate analysis of food samples as per standard protocols. - Review and validate test results, ensuring proper documentation in LIMS or lab records. - Oversee calibration, maintenance, and troubleshooting of instruments such as muffle furnace, Soxhlet apparatus, Kjeldahl unit, and moisture analyzer. - Implement and monitor adherence to Good Laboratory Practices (GLP) and ISO/IEC 17025:2017 guidelines. - Train and mentor team members to enhance skills and maintain high performance. - Prepare and review SOPs, work instructions, and risk assessments related to proximate testing. - Support internal and external audits, participate in corrective and preventive actions (CAPA). - Coordinate with other departments for sample processing, reporting, and client queries. - Drive continuous improvement initiatives within the department. Qualifications & Skills: - Bachelors or Masters degree in Food Technology, Chemistry, Biochemistry, or related field. - 8-11 years of relevant experience in proximate analysis in a food testing laboratory. - Strong understanding of standard food testing methodologies and regulatory requirements (FSSAI, BIS, AOAC, ISO). - Familiarity with laboratory instruments and their routine maintenance. - Excellent communication, leadership, and team management skills. - Proficient in documentation, quality management systems, and audit handling. - Attention to detail and ability to work in a fast-paced environment. Preferred Certifications: - Training in ISO/IEC 17025:2017 - Internal Auditor Certification (ISO 17025 or ISO 9001) - HACCP/FSSAI/Food Safety related training This is a full-time position with benefits including food, health insurance, paid sick time, and Provident Fund. The work schedule is a day shift with shift allowance and yearly bonus. The work location is in person.,

As an Account Manager at Waters, you will be a key representative of the company, driving the promotion and sales of Waters products and services in Ahmedabad, Gujarat. Waters, a pioneer in specialty measurement solutions, focuses on innovation and diversity to support customer success in various scientific fields. Your role will involve understanding customer needs, developing solutions, and fostering long-term relationships for mutual success. Your responsibilities will include engaging with customers across diverse markets such as Pharma, Biopharma, Chemical materials, Food, Environmental, Clinical, and Academia. You will be tasked with maintaining existing accounts, identifying new opportunities, and delivering technical advice to maximize sales potential. Collaborating with internal teams, organizing seminars, and implementing business plans will be crucial aspects of your role. To excel in this position, you should have a Bachelor's Degree, Masters, or PhD in a scientific field like chemistry, biology, or biochemistry. Experience in Liquid Chromatography, Sample Preparation, and technical solution selling will be valuable. Strong communication, organizational, and interpersonal skills are essential for effectively engaging with customers and internal stakeholders. This role requires frequent travel within your designated territory, as well as occasional international travel for business activities. Waters Corporation, a global leader in analytical instruments and separations technologies, has been serving diverse industries for over 65 years. Join us in our mission to ensure product efficacy, food safety, and environmental sustainability through innovative science and collaborative partnerships.,

As a candidate for this role, you should hold an M. Sc. degree in Analytical Chemistry and possess practical experience in method development and validation. Your responsibilities will include working in shifts and contributing to analytical development laboratory activities. The ideal candidate should have a minimum of 2 to 5 years of hands-on experience in a similar role.,

As an individual with a Master's degree in Analytical Chemistry and 6-9 years of experience in method development and validation, you will be responsible for contributing to the success of the organization. Your expertise in analytical chemistry will be utilized to develop and validate methods that meet the required standards. In this role, you must be prepared to work in shifts to ensure the smooth operation of the analytical processes. Your ability to adapt to a changing work schedule will be crucial in meeting the demands of the job and maintaining the quality of the analytical results. Overall, your experience and skills in analytical chemistry, combined with your willingness to work in shifts, will be instrumental in achieving the objectives of the organization and driving success in the field.,

Job Summary Job Title Research Associate I Location Whitefield, Bangalore Shift General Essential Duties and Responsibilities: Independently and successfully execute experiments towards method development, method validation, specifically for extractable and leachable profiling studies, within specified timelines. Make sound technical recommendations in routine analytical activities. Provide analysis/redesign of key experimental procedures. Produce scientific experimental data based on written procedures like method of analysis, protocols etc. Involve in and conduct trouble shooting of analytical methods, laboratory investigations etc Provide input to select analytical techniques and procedures to solve problems within area of responsibility. Apply technical theories and principles to projects within area of expertise. Independently analyze and propose solutions to research challenges. Learn newer analytical techniques to enhance the capability and productivity. Author documents like Method of analysis/ protocols/ reports Perform/ provide support as needed in calibration and maintenance of equipment in the laboratory. Participate and take ownership of equipment installation and qualification activities as per QMS. Document laboratory work performed pers GDP. Work according to appropriate quality standards and quality principle (e.g., Data Integrity, ALCOA) Follow Quality Manual, SOPs, and Environmental Health, Safety & Sustainability (EHS&S) guidelines in day-to-day activities, to ensure proactive compliance and continuous improvement. Qualifications: Hands-on experience in chromatographic and/ or spectral techniques like LC-MS/MS, GC-MS, and/or ICP-MS/ ICP-OES. Operation of analytical tools/ instruments (weighing balances, pH meters etc.) and wet chemistry sample preparation techniques. Should have analytical problem-solving skills, high learning agility, innovative experimental attitude along with good presentation skills. Excellent written and verbal communication skills in English. Demonstrates an inclusive attitude and an ability to collaborate with team members and cross-functional team members for project deliverables. Ability to objectively assess, organize, and clearly communicate information. Ability to interpret available information and make recommendations to resolve technical challenges. Ability to appropriately prioritize work assigned to meet project deliverables in a timely manner. Provide and accept critical feedback from others in a constructive manner. Adapt to changes and have an agile mindset. Embrace diversity and inclusion, value differences. Education and/or Experience: Educational Qualification: Postgraduate/ Ph. D. in Pharmacy/ Chemistry or related field (M. Pharm./ M. Sc./ Ph. D.) Professional Experience: 3 to 6 years of relevant experience

1. Supervise end to end operations of food Chemical lab maintain the TAT for all the samples. 2. Implementation of Quality System as per all applicable accreditations like ISO 17025, FSSAI, EIC, APEDA etc. 3. Maintain all relevant documentation and presents as needed for quality audits and Regulatory audits 4. Implementation and Complying to the other TUV SUD Process and Policies 5. Implementation of good laboratory practices 6. Ensure on time method development / verification and validation 7. Implementation of any new process as decided by the management 8. Monitoring the turnaround time of the sections / reports as per the given schedule 9. Testing capability confirmation to sales and co-ordination with sales team for smooth lab operation. 10. Immediate response to internal or external enquiries. 11. Implementation of the safety guidelines for the respective areas 12. Minimize wastages inside the laboratory 13. Support in data inputs for new investment planning 14. Regular employee engagement 15. Driving continual improvements projects 16. Monitoring Expenses and take the required actions as on required 17. Coordinate and ensure Calibration / Preventive Maintenance / repair schedule with adequate documentation. 18. Equipment /method troubleshooting / repairs 19. Shift management and leave Management of the lab team 20. Supporting technical manager for RCA and CAPA 21. Ensure on-time training of respective team as per training planner Roles and Responsibilities 1. Supervise end to end operations of food Chemical lab maintain the TAT for all the samples. 2. Implementation of Quality System as per all applicable accreditations like ISO 17025, FSSAI, EIC, APEDA etc. 3. Maintain all relevant documentation and presents as needed for quality audits and Regulatory audits 4. Implementation and Complying to the other TUV SUD Process and Policies 5. Implementation of good laboratory practices 6. Ensure on time method development / verification and validation 7. Implementation of any new process as decided by the management 8. Monitoring the turnaround time of the sections / reports as per the given schedule 9. Testing capability confirmation to sales and co-ordination with sales team for smooth lab operation. 10. Immediate response to internal or external enquiries. 11. Implementation of the safety guidelines for the respective areas 12. Minimize wastages inside the laboratory 13. Support in data inputs for new investment planning 14. Regular employee engagement 15. Driving continual improvements projects 16. Monitoring Expenses and take the required actions as on required 17. Coordinate and ensure Calibration / Preventive Maintenance / repair schedule with adequate documentation. 18. Equipment /method troubleshooting / repairs 19. Shift management and leave Management of the lab team 20. Supporting technical manager for RCA and CAPA 21. Ensure on-time training of respective team as per training planner

Job Title: Invitro BA Scientist Job Location: Bangalore, Hyderabad' About Syngene : Syngene (www.syngeneintl.com) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit Mandatory expectation for all roles as per Syngene safety guidelines • Overall adherence to safe practices and procedures of oneself and the teams aligned • Contributing to development of procedures, practices and systems that ensures safe operations and compliance to companys integrity & quality standards • Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. • Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. • Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self • Compliance to Syngene s quality standards at all times • Hold self and their teams accountable for the achievement of safety goals • Govern and Review safety metrics from time to time Core Purpose of the Role : • To participate in sample processing for PK, ADME assays and handling of LCMS/MS. Ability to adapt to the dynamic team environment • Processing of different matrices samples of PK studies • Optimization of test compounds manually as well as automated on LCMS/MS • Develop methods with the team lead • Independently handling of HPLC for UV based samples analysis. • Documenting the lab note books online and compound management Syngene Values All employees will consistently demonstrate alignment with our core values ' Excellence Integrity Professionalism Experience 3- 10+years Education : Msc/Pharm/Mtech/Phd/ Fresh phd with relevant exp during academics or any postdoc Skills and Capabilities • Expertise in column selection, mobile phase selection, solvent preparations and sample processing techniques such as protein precipitation, liquid-liquid extraction and solid phase extraction is mandatory • Sample processing of New chemical entities from various in-vitro and in-vivo studies executed in Preclinical discovery by using appropriate extraction methods • Should be able to develop and validate LC-MS based qualitative/quantitative methods and apply them in routine analysis • Should be well versed with internet-based literature search and capable of implementing the Learnings as and when required • Candidate is expected to have basic understanding in interpretation of Mass/UV Spectra • Should ensure preventative maintenance and calibration schedules of HPLC & mass spec by coordinating with vendor and support staff • General understanding of Drug metabolism and Pharmacokinetics • Should be able to deliver scientific presentation in departmental journal club and write official Project reports

Walk-In Drive For Formulation Analytical Research & Development(FAR&D)- MSN Laboratories, R&D Center, Pashamylaram, Hyderabad on Friday 25-07-2025. Requirement for Executive - FAR&D - Formulation Analytical Research & Development(FAR&D) Undertake method development, troubleshooting and method validation to GMP and ICH. Investigation of non-conforming samples, CAPAs, data evaluation and reporting. Write cGMP Quality documents including Standard Operating Procedures, laboratory equipment procedures and investigational protocols. Excellent, enthusiastic, clear communication skills, both written and verbal, with a diverse audience are critical to the success of this position. Proven ability to interact with cross - functional and cross - cultural teams. Previous experience of running analytical techniques such as HPLC, Dissolution, KF, IC with the ability to extract and prep various samples in a variety of forms. As this role involves liaising with other departments on a regular basis, you will need good communication skills and the ability to work effectively as part of a team. Note : Formulation Quality Control Candidates also eligible. Interview Date : 25-07-2025 Department : Formulation Analytical Research & Development(FAR&D) Experience : 1 to 6 Years Qualification : M. Pharmacy / M.Sc. / B Pharm Position: Executive Work Location : MSN R&D Center, Pashamylaram, Hyderabad Interview Venue Details MSN Laboratories, R&D Center,Pashamylaram, Hyderabad

Exp: 2- 6 yrs • Knowledge in Method Development on Assay, RS, dissolution for formulation complex molecules. • understanding of Q1/Q2 evaluation • PEQ processes and characterization • Instruments: HPLC, GC, KF, UV, IR, etc. pranathi.p@orbicular.co.in

Aspirant should have experience in GC-MS Caliber to handle Method Development, Validation, and Stability studies. Regulatory requirements (like USFDA, MHRA, EMA, and other Markets) Coordinating with the Should have GLP, ALCOA+, GDP, QMS

We invite Postgraduates and Ph.D. holders to participate in our Walk-in Drive and become a valued part of the Althera family. Please carry a copy of the following documents with you: Updated Resume Recent Payslips/Increment letter and appointment letter Relieving Letter (if applicable) Educational Qualification Certificates We look forward to meeting talented professionals like you. Join us and take the next step in your career with Althera! Roles and Responsibilities Candidate should be very strong in Method development on HPLC for assay, Relates substances & dissolution for Regulated and Semi-regulated markets for tablets & capsules. Should have knowledge on Analytical Method Validation Analytical Method Transfer. Well versed with Regulatory guidelines (ICH and EU). The candidate should be ready to work full time in the lab. Desired Candidate Profile Masters degree or Phd in Pharmacy or Chemistry 1 to 6 years of experience in Solid dosage forms or experience in Peptides (Injectable and solid dosage form). Handling of instruments like HPLC, Dissolution apparatus, UV-VIS spectrophotometers etc. Understand the ICH and other guidelines Preparation and review of Department SOPs. Good knowledge on analytical method development, validations, transfer, stability analysis etc. Candidates from Testing labs can also apply.

As an Assistant Manager or Team Leader at Synnat Pharma in Visakhapatnam, you will play a crucial role in leading method development, validation, stability studies, and technology transfer activities. Your meticulous nature and extensive experience will be essential in collaborating closely with R&D, QC, and Regulatory teams to support product development and ensure compliance with global pharmaceutical standards. You should possess strong analytical expertise, leadership skills, and a dedication to regulatory compliance and continuous improvement. Your responsibilities will include developing, optimizing, and validating analytical methods such as HPLC, GC, UV-Vis, and Dissolution according to ICH and regulatory guidelines. You will be responsible for preparing and maintaining validation protocols, analytical reports, and ensuring compliance with Good Documentation Practices (GDP). Additionally, you will oversee method transfer to QC, provide training, and address any troubleshooting issues that may arise. Conducting stability studies, preparing data reports, and collaborating with cross-functional teams to support product development will also be part of your role. Furthermore, you will be expected to investigate and resolve analytical issues, including OOS, OOT, and deviations, and implement Corrective and Preventive Actions (CAPAs) as necessary. Maintaining up-to-date documentation and ensuring compliance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) will be integral to your responsibilities. You will also evaluate vendors and key starting materials (KSMs) and provide insights to management based on your findings. In terms of past experience, you should have a strong understanding of analytical chemistry principles and techniques, including HPLC, GC, Dissolution, and UV-Vis. Proven experience in method development, validation, and regulatory compliance is crucial for this role. Familiarity with global pharmaceutical regulations such as those from the FDA, EMA, WHO, and ICH guidelines is essential. You should also be skilled in handling regulatory submissions and documentation, possess excellent problem-solving abilities, and have experience mentoring R&D scientists. Familiarity with CAPA systems and good documentation practices will further strengthen your candidacy for this position.,

As an ideal candidate for this role, you should possess a minimum of 2 years to a maximum of 6 years of experience in handling Analytical instruments such as HPLC and GC. Your primary responsibilities will include conducting routine analysis using these instruments and participating in method development processes. Your expertise in analytical techniques will be essential in ensuring accurate and reliable results.,

You will be responsible for performing analyses of Drug Product and Drug Substances to evaluate various test parameters as per product development requirements. This includes Method Development of Drug Product and Method verification of Raw Materials. Additionally, you will compile analytical results and prepare Method Development Reports. It is essential to ensure adherence to GLP aspects in the analytical laboratory to maintain quality and accuracy in testing processes. The ideal candidate should have 0 to 3 years of experience in a similar role.,

Role & responsibilities Analysis of Routine and Stability samples using instruments like HPLC , UHPLC (Shimadzu), GC.UV spectrophotometer, IR, KF titrator and Dissolution tester. Having Experience in handling of Instruments, Like Analytical Balance, pH meter, KF Titrator, UV spectrophotometer, HPLC, UHPLC, Dissolution tester, GC is preferable Perform Calibration of instruments or equipment Like HPLC, Dissolution. Understanding of wet chemical analysis like: Titration, LOD, KF , IR, UV etc. Maintain analytical documentation records and online documentation of experiments. Understanding of analytical method development Activity. Execute routine Analytical research activities of drug products Follow GLP and safety in the laboratory as per regulatory guidelines. Responsible for any other assignment allocated by the Department Head.

NOTE: Only Male & Candidates from AP & Telangana Preferred. Kindly Understand the JD It's not for the Clinical Trails Department 2Years Bond & Need to Submit your 10th Original Mark list with us during the Bond Period. Qualifications required: Bachelors / Master's in Pharmacy, M.sc Chemistry/Organic Chemistry (2023/24/25 Passed outs with certificates in hand) Role and responsibility: In process quality control of ongoing studies. Review of raw data, chromatograms and reports of the method validations and studies. Checking of all the instruments and equipments for the calibration status and appropriate labeling. Checking and monitoring of the day-to-day activities in the lab for compliance to SOPs and GLP principles. Checking of the concentration data of subject samples before releasing to PK department. Generation, control and distribution of method SOPs. Logbook handling and archival of the completed logbooks. Performing the routine glassware validations and monitoring of the temperature and humidity in the Bio-analytical lab. Calibration of pipettes and multipedes. Coordinating for training programs on SOPs. Ensure cleanliness of laboratory and disposal of non-bio-waste & Bio-waste.

As a member of our team, your primary responsibilities will include the development and validation of methods for Assay, Dissolution, and related substances. You will also be responsible for the calibration of analytical instruments to ensure accurate and reliable results. Conducting routine and stability samples analysis of OSD formulations will be a key part of your role. To excel in this position, you must possess a good quality mindset and have a thorough understanding of GLP requirements. Your ability to write technical reports and prepare power point presentations will be essential for effectively communicating your findings and recommendations. Join us in this dynamic role where you will play a crucial part in ensuring the quality and accuracy of our analytical processes.,

You will be joining USP's Global Biologics department as a Sr. Scientist - I (RSS-Review), where you will play a crucial role in supporting the development of USP documentary standards and reference standards for biological products. In this hands-on, non-supervisory position, you will be responsible for ensuring the accuracy, clarity, and compliance of scientific documents, managing the reference standard stability program, and driving continuous process improvements. Your primary responsibilities will include performing technical and quality reviews of documents, developing and reviewing SOPs and training materials, assisting in investigations of quality-related issues, and collaborating with internal stakeholders to develop new standards for analytical analysis of biological products. You will also be involved in maintaining the reference standard stability program, reviewing testing data, preparing stability trend reports, and updating databases to document laboratory data and program determinations. To succeed in this role, you must have a PhD degree in Biochemistry/Biology/Pharmacy or a related field with 7 to 10 years of experience, or a Master's degree with 11 to 13 years of experience. You should have demonstrated expertise in technical review of analytical documents in Quality Assurance and hands-on experience with analytical techniques for characterizing biological products. Strong communication skills, both written and verbal, along with the ability to work collaboratively with internal and external stakeholders, are essential for this position. Additionally, knowledge of USP products and services, experience in the pharmaceutical or biotechnology industry, and the ability to work effectively in a fast-paced environment are desired preferences. While there are no supervisory responsibilities associated with this role, you will be expected to take ownership of your work, ensure timely delivery of tasks, and maintain the highest quality standards. USP is committed to providing comprehensive benefits to protect the well-being of you and your family, including paid time off, healthcare options, and retirement savings. By joining USP, you will contribute to the organization's mission of increasing equitable access to high-quality, safe medicine and improving global health through public standards and related programs.,

SENIOR QUALITY CONTROL ANALYST Job Objective: The Quality Control (QC) Analyst specializing in Method Validation and Method Development is responsible for developing, validating, and transferring analytical methods for pharmaceutical raw materials, intermediates, and finished products. The role ensures compliance with regulatory requirements and contributes to continuous improvements in analytical methodologies. Qualifications: Bachelors/Masters degree in Pharmaceutical Sciences, Chemistry, Analytical Chemistry, or related field. Experience: More than 8 years of experience in method validation, method transfer, and regulatory compliance within a pharmaceutical QC or analytical development environment. Job Responsibilities: Method Development & Optimization: Develop and optimize analytical methods for assay, dissolution, related substances, and residual solvents using techniques like HPLC, GC, UV-Vis, FTIR. Establish and refine chromatographic conditions, mobile phases, and detection parameters for improved sensitivity and reproducibility. Conduct forced degradation and stability-indicating method development as per ICH Q1A guidelines. Method Validation & Transfer: Perform method validation as per ICH guidelines covering accuracy, precision, specificity, linearity, robustness, and system suitability. Prepare and review method validation protocols and reports. Execute method transfer activities between R&D, QC, and manufacturing sites following GMP requirements. Regulatory Compliance & Documentation: Ensure analytical methods meet US FDA, EU GMP, MHRA, WHO, and other regulatory expectations. Maintain accurate documentation as per Good Documentation Practices (GDP). Support regulatory filings by preparing analytical method validation reports and technical dossiers. Assist in responding to regulatory queries and audits related to analytical methods. Instrumentation & Troubleshooting: Operate and maintain analytical instruments such as HPLC, GC, UV-Vis, FTIR, and dissolution testers. Troubleshoot chromatographic issues related to retention time shifts, peak tailing, and resolution problems. Participate in instrument qualification (IQ/OQ/PQ) as needed. Collaboration & Process Improvement: Work closely with R&D, Manufacturing, and Quality Assurance teams for seamless method transfer. Investigate out-of-specification (OOS) and out-of-trend (OOT) results to identify root causes. Contribute to continuous improvements in analytical techniques and laboratory efficiency. Technical Skills: Strong expertise in HPLC, GC, UV-Vis, FTIR